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Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00788034
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: Lu AA21004 Drug: Placebo Phase 3

Detailed Description:
GAD is a common and disabling mental disorder associated with substantial medical and psychiatric comorbidity and occupational impairment. It is characterized by inappropriate or excessive anxiety and worrying that persists over time for more than six months. Common features include apprehension, with worries about future misfortune; inner tension and difficulty in concentrating; motor tension, with restlessness, tremor and headache; and autonomic anxiety symptoms, with excessive perspiration, dry mouth and epigastric discomfort. GAD is typically a chronic disorder with a high relapse rate and therefore requires effective long-term treatment. Long-term studies are necessary to demonstrate that the short-term effect is maintained.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder
Study Start Date : October 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Lu AA21004 Drug: Lu AA21004
5 or 10 mg/day
Other Name: Vortioxetine

Placebo Comparator: Placebo Drug: Placebo
Once daily

Primary Outcome Measures :
  1. Time to relapse [ Time Frame: At least 24 weeks ]

Secondary Outcome Measures :
  1. Relapse rates, Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression Scale (CGI), MOS SF-36, Sheehan Disability Scale (SDS), Adverse events, Clinical laboratory tests, Vital signs, ECG [ Time Frame: At least 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The patient has GAD as the primary diagnosis according to DSM-IV-TR criteria (classification code 300.02).

  • The patient has a HAM-A total score >=20 at screening and baseline visits
  • The patient has a HAM-A score >=2 on both Item 1 (anxious mood) and Item 2 (tension) at screening and baseline visits
  • The patient has a MADRS total score <=16 at screening and baseline visits

Exclusion Criteria:

  • Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (assessed with the MINI)
  • Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR
  • Women of childbearing potential not using effective contraception

Other protocol-defined inclusion and exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00788034

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Sponsors and Collaborators
H. Lundbeck A/S
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Study Director: Email contact via H. Lundbeck A/S

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S Identifier: NCT00788034    
Other Study ID Numbers: 12473A
2008-001673-15 ( EudraCT Number )
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: December 2012
Keywords provided by H. Lundbeck A/S:
Relapse prevention
Additional relevant MeSH terms:
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Anxiety Disorders
Pathologic Processes
Mental Disorders
Disease Attributes
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists